50 Years Of Global Health Progress – Interview With IFPMA Head Thomas Cueni

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in his inaugural speech at the World Health Assembly this week, explained that partnerships are a key strategy for the WHO to ensuring healthy lives and promoting well-being for all at all ages.  He added that the WHO is engaging with the private sector as a crucial partner in achieving health for all. Thomas Cueni, IFPMA’s Director General, in an interview with Health Policy Watch on the occasion of the IFPMA’s 50-year anniversary, explains how the research-based biopharmaceutical industry together with IFPMA have contributed to the huge strides in health progress over 50 years. He explains the major leaps forward, setbacks and mistakes, as well as how industry is part of the solution, as “do-ers” and partners in global health progress.  Cueni also talks about pricing and cost of R&D.  

HEALTH POLICY WATCH (HPW): Could you tell us something about the Report on 50 years of the Global Health Progress and how the pharmaceutical industry and how IFPMA has changed since it was set up back in 1968?

THOMAS CUENI: A 50th anniversary is a time to take stock of what has been achieved and what has fallen short and why. I am surprised when I talk to people about how today’s world compares to 50 years ago and, all too frequently they say it’s ‘much worse’ when quite the opposite is true. When we compiled the 50 Years of Global Health Progress report, what shone out was that transformative progress has been made over that period: people live longer, are healthier and have a better quality of life irrespective of where they live.

The report has consciously homed in on just seven areas of innovation to show the extent of change. The report looks for example at the progress achieved in transforming HIV/AIDS from a deadly disease to a chronic illness is not simply an example of innovation at work but also of a sea-change in access to new treatments. Another area highlighted are the millions of treatments for neglected tropical diseases [NTDs] that are reaching people in some of the poorest parts of the world. We also trace the progress made in treating not one, but scores of types of cancers. Then, progress in treating cardiovascular disease tends to be forgotten, but a quick look back into history, and no less than three US presidents (Truman, Eisenhower and Johnson) died of what is now preventable heart disease. Today’s treatment for diabetes type 1 is like day and night compared with 50 years ago, with new formulations and far easier management of the illness radically improving the lives of sufferers. Hepatitis C used to be a fatal disease, extremely costly to treat and, now, it is curable within 8 to 12 weeks. This is just a snapshot of the astounding progress achieved, a process in which R&D based biopharmaceutical innovation has played a key role.

HPW: Looking back into the past is useful, but how does it apply now?

CUENI: The report marks 50 years since IFPMA was established but celebrating this milestone is not our sole purpose. The intent behind the report is to take stock of the tremendous progress made but to drive home the message that much more needs to be done to bring the fruits of our innovation to all.

We have chosen to launch the report at an event coinciding with the World Health Assembly that gives us reason to reflect on our mistakes and discuss the challenges remaining. There is plenty to discuss. Top of the agenda is the fact that 60 % of the world’s population have to pay for their medicines out of their own pockets. For many, even 20 cents a day may be too much for somebody who has $2 a day as disposable income or even less to live on. We have invited Tim Evans from the World Bank to explain how the UHC nut needs to be cracked. Dame Sally Davis, chief medical officer of the UK, is in my opinion the global champion on antimicrobial resistance. This is an issue that has been creeping up on us over past decades to become a full crisis, with today an estimated 700,000 people dying each year of antibiotic resistant diseases. A huge worry is that this number, already a source of great anxiety, could increase to 10 million a year by 2050. These are just two enormous challenges the global health community faces now and in the years ahead. But ones we are determined to tackle.

HPW: IFPMA is calling for more partnerships, and Dr Tedros also made reference to this in the opening speech of the WHA, how do we know if they really have an impact on improving global health?

CUENI: Vaccination is a great area to demonstrate the impact of innovation combined with partnerships. GAVI Alliance is a crucial initiative which, in partnership with the R&D based biopharmaceutical industry, has brought great progress. Now, thanks to GAVI, you have vaccination rates in low income countries (LDCs) which are almost equal to those in industrialized countries. Back in 1971, the MMR vaccine in one shot was approved in 1971. Today vaccines have been developed to prevent 26 diseases. Vaccines are proven to be one of the most effective and cost efficient medical technologies ever developed. Immunization saves between 2 and 3 million children’s lives per year. However, looking at the challenges remaining, vaccination rates are much lower in crisis countries, conflict countries, and they even lag behind in middle income countries.

HIV/AIDS is another area where partnership have led to tremendous progress. The Global Fund [for AIDS, Tuberculosis and Malaria] backed by the private sector allowed countries to provide coverage to patients who would not even have been able to gain access to very cheap generic medicines. There is also the Medicines Patent Pool. This partnership has negotiated voluntary licenses concerning HIV/AIDS with companies so that the most recent treatments are available. I can recall the late 1990s when the average treatment regime with ARV (antiretroviral) drugs involved more than 20 medicines per day, which was daunting. Today, modern treatments for HIV/AIDS are what is called combination drugs, vastly increasing the chances that the patient will follow the regime, with fewer side effects and more easily administered, so the chances of people surviving with HIV/AIDS are infinitely better. Today, there is a willingness, which did not exist 20 years ago, on the part of companies to enter into voluntary licensing agreements and offer their patented drugs to generic companies so that they are made more widely available. There are other partnerships involving the R&D based pharmaceutical industry, including: MMV, TB Alliance, FIND, DNDi, the London Declaration on NTDs. Industry’s willingness to enter into partnerships that make a difference is clear and sustained.

HPW: Can you explain why IFPMA is calling for more partnerships?

CUENI: Because much, much more needs to be done in working together to ensure access for all patients. Sadly, as was evidenced by the WHO Executive Board meeting in January, some hyper-critical people seem to prefer to stick in their trenches, shouting about the mistakes of 30 or 20 years ago. For them, this is their rationale for why we cannot work together today. Such attitudes are way behind the times and ignore the tangible evidence that today, I am proud to say, there is a willingness within the private sector to reach out, to work in partnership. In fact, partnerships have a dedicated SDG of its own – SDG 17. This is also reflected by my recent experiences in Montevideo at the NCD Summit in October and the WHO and Danish government conference (global dialogue) on innovative partnerships for financing prevention and control of NCDs earlier this year. At these meetings, there was near unanimous agreement on the need to partner with industry.

HPW: What are you doing to scale up the partnerships?

CUENI: This last year, we have launched a number of partnerships. The AMR Industry Alliance was set up in May 2017 with more than 100 companies and associations from biotech, diagnostic, generic and R&D based biopharmaceutical companies. Tracing the progress of this new partnership, we produced a report that was surprising and counterintuitive in that it showed industry in 2016 invested 4 times more in antibiotic research than all governments put together. So, here again, while the perception may be that the drive for funding research into new antibiotics is coming from governments such as the US; the UK and Germany, this is clearly not the case. We can honestly and humbly admit that the current R&D spend is not enough by far but increasing R&D spending requires a healthy dialogue on finding the best solutions.

We must make our partnerships even deeper and stronger. Dr Tedros’ opening speech on Monday at the World Health Assembly made that very point: “By leveraging the experience, skills, resources and networks of our partners, our impact can be exponentially larger than if we were acting alone.” And he added, “We’re engaging with the private sector, who will be a crucial partner in achieving health for all…“

New types of partnerships are emerging. For example, with the World Bank and UICC through the Access Accelerated, a unique collaborative initiative of over 20 innovative companies that seek to build the health system structures and partnerships needed to make access to treatments possible. The UICC partnership aims to bring solutions to the rise in NCDs in cities (to date: Asunción, Paraguay, Cali, Colombia, Yangon/Myanmar and Kumasi, Ghana). With the World Bank, we work on strengthening health systems in Kenya together with the Minister of Health from Kenya and the NGO AMPATH. We share experiences and discuss what lessons from the successes of communicable diseases could be replicated in tackling NCDs. There is a willingness to analyse what are the real reasons for shortcomings, for example medicines failing to reach sufficient patients.

In low-income countries, by the time insulin reaches the patient it can cost up to five times more. Improving access requires navigating a complex value chain such as mark-ups along the supply chain. Access to medicines is not about price alone it encompasses health system strengthening , effective supply chain management, timely  diagnosis, availability of primary care, regulatory capacity building and UHC. We must move from narrow views and polarized  debates on access and approach this from holistic and partnership approach

HPW: What do you say to those who might fear that the R&D model is broken and that’s the reason the industry is unable to price medicines fairly?

CUENI: The past 50 years of global health progress have shown that our R&D model has delivered “big time”. It certainly is not broken. Nothing is further than the truth. When you look at the transformative changes made in cancer, hepatitis C, rheumatic arthritis, vaccines, we have never seen so much innovation in such a short timeframe. This remarkable innovation is very much driven by competition but also by more collaborative research. Hopefully, we will see even more collaborations around global innovation platforms for early stage R&D to make for faster and more efficient breakthroughs. Effective collaborations require rewards for innovation based on a strong IP system. There remain many huge scientific challenges such as dementia, Alzheimer’s and CNS. However tried and tested the competitive model is, there are areas like antimicrobial resistance where R&D investments become too high-risk, in this case because there is no marketplace so, when a new antibiotic is found, it will need to be kept in reserve and used only as a last resort. Companies are investing in R&D for antibiotics but given the potential danger resistance represents they should ideally invest much more. If they were for example given market-based incentives; it would be easier to justify the investment. That is why we really need to foster the debate on R&D in AMR and in other areas such as NTDs, TB and malaria where more collaborative efforts would be the way forward.

HPW: Is this just a way to put off substantive change, and a good excuse not to be doing R&D in areas where it’s difficult?

CUENI: Definitely not. Even in difficult areas where the market is potentially restricted, we have made progress. One of the big public health challenges is tuberculosis and multi-drug resistant tuberculosis (MDRT). Recently, we have seen for the first time in 50 years two really new TB treatments, both from private companies, reaching patients including through access initiatives of the respective innovative companies.

HPW: We can see that a broader element of people in Europe and other developed regions is concerned about the price of medicines. It is an access question. Why is there this perception now? Why have certain medicines become inaccessible to people in developed countries? Is it only a few random cases that don’t fit the model? Or did something happen that has brought them to this idea?

CUENI: I am very sensitive to this debate. We are very much involved with the OECD study on Sustainable Access to Innovative Medicines, where similar questions have been raised. There is no denying there is a fierce debate on healthcare costs and there is a challenge to the industry to step up to the plate and demonstrate the value of medicines. Industry in my experience is now willing to move from the classic transactional contract, which means you are paid for selling a product, to payment for achieving a certain health outcome.

To date, notwithstanding the transformative innovation pharmaceutical research has brought in areas such as Hep C or many cancers, overall there is no evidence from OECD countries that aggregate drug spending has gone up let alone become unsustainable. The pharmaceutical market is very dynamic. Twenty years ago, cardiovascular disease expenditure was by far the biggest and now it has shrunk even though the number of patients has gone up. In contrast, spending on cancer drugs has increased. Therefore, sustainable funding is about aggregate figures. Many of the forecasts about health care budgets going bust because of high prices are flawed because they underestimate price competition while patents are still valid, as was the case in the Hep C market.

HPW: But what about the system of innovation when there is no market? Then we have to assume that the prices become exorbitant?

CUENI: Incentive systems can and have worked, specifically in the case of rare disease. Thanks to modern biotechnology, and thanks to the incentives put in place by governments, the number of orphan drugs approved has gone up from 20 to over 400. The issue about one individual patient costing a million in treatment for a rare disease is an extreme case since the costs vary depending on whether there are a thousand or just 5 patients that have this rare disease.

HPW: Looking back at 50 years of global health progress, can you describe how your membership has changed, the way IFPMA has evolved in its representation of them, and how what you do on a day-to-day has changed from before?

CUENI: IFPMA used to be an association of associations. Today IFPMA has over 40 member associations from around the world and 35 pharmaceutical research companies of which 2 are also the world’s leading producers of quality generic medicines .Since I joined the association we gained six new members, 5 companies and one national association. This reflects a very dynamic and positive development. What has not changed are the criteria for membership: one, Commitment to Research & innovation, two, Support for Intellectual Property Protection, and three, Ethics and business integrity.

HPW: How do you describe the service provided by this organization?

CUENI: IFPMA first and foremost represents the R&D based biopharmaceutical industry in the global health capital of the world that is Geneva. Since IFPMA membership has an official status with ECOSOC, within the UN system, with WHO, it means that we are invited to fora of dialogues to share our expertise and knowledge. IFPMA attends the NCD meetings in Copenhagen and Montevideo. We send a delegation to the World Health Assembly. IFPMA has always played an active role in explaining and supporting the industry’s business model and the value it brings to global health progress, and this is one of our main missions. IFPMA also has a long tradition of partnerships and innovative solutions. In this area, we Increasingly see an interest among R&D based biopharmaceutical companies of being aligned and acting jointly. 10, 15 years ago, most of the big pharma companies ran their own access programmes. These individual companies do and hopefully will continue to do great things. But in terms of getting credit, it helps if you act in unison as an industry. When you look at the relationships IFPMA has in Geneva, I see an opening for the framework of engagement with non-state actors (FENSA). At one time it looked like a framework was an excuse for non-engagement. Today, I see a willingness to engage with the private sector, not only in institutions such as the Global Fund, MPP, or the MMV. With WIPO, we signed a memorandum of understanding on Pat-INFORMED that was highly appreciated. IFPMA also entered into a collaboration with the Graduate Institute and Chatham House, where we support this Africa Health Fellowship Program with ten fellows over the next two years. I feel very encouraged by this partnership and was impressed by the initial fellows who mentioned their intent to remain in their countries – Ghana or Nigeria – rather than going to London or Geneva, as a motivating factor for their fellowships.  I see a lot of changes and positive developments though there are some trenches that remain.

HPW: Are the partnerships truly addressing the problem of access to medicines?

CUENI: We are and will do more to get into new partnerships and new liaisons so that more patients have access to our medicines. We have engaged in partnership with UICC for the city cancer challenge and the World Bank for pilots on health systems strengthening, and I hope that we are in discussions on accelerating access to innovative medicines with WHO. I certainly hope that these pilot projects will be a success and if so they will be scaled up. We should not underestimate the challenges. I don’t see a global fund for NCDs, so we have to come up with new solutions. WHO has rightly emphasised the importance of Universal Health Coverage (UHC) and domestic funding.

HPW: But surely fair pricing is a, if not the, key issue and more and more people are engaged in bringing it about, don’t you think?

CUENI: Obviously we can’t ignore the debate about access and affordability. But I believe that there is an increasing recognition that the simple focus on price does not do justice to the multiple access barriers such as lack of UHC, the fact that 60 per cent of the world population pay their medicines out of packet, lack of health care workers, and weak health care systems. If we want to make progress, we need to tackle these problems holistically. Clearly, the industry will also have to play its part, and I see a willingness to engage on a much larger scale on how to bring innovative medicines to millions of more patients in developing countries. The challenge here is that progress also depends on richer countries being willing to pay more than poorer countries. I have seen radical examples of tiered pricing in the hepatitis C area, the product was leaking everywhere and of course not always to the patients for whom the lower price was meant. However, compared to ten years ago, R&D based pharmaceutical companies are much less risk averse and believe that there are ways and means to introduce tiered pricing models.

HPW: Finally, at this year’s World Health Assembly (WHA), can you describe some of the key priorities and events, and policy items for IFPMA?

CUENI: Overall, when you look at the General Programme of Work, the WHO is really trying to achieve an impactful outcome, a willingness to be held accountable. The emphasis on UHC and on NCDs is one of the biggest shifts over the last few years, from communicable disease to non-communicable disease. I also see a successful effort of positioning WHO at a higher level of global political discussions, not just among Ministers of Health. He is pragmatic and clearly result-oriented. That’s encouraging.

HPW: Thank you.

 

Image Credits: IFPMA.

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